Manually articulated intubation stylet, intubation device and intubation method

ABSTRACT

Apparatuses useful in and methods for positioning of an endotracheal tube within an airway by allowing manual articulation of the endotracheal tube while a patient is being intubated. The apparatuses and methods are of particular use in intubating patients with unique anatomical conditions that make standard stylets inadequate for intubation. In one embodiment, an apparatus may comprise a stylet having a first end and a second end, with the second end of the stylet being insertable within a lumen of the endotracheal tube. First and second articulatable portions of the stylet may be independently articulated into respective primary and secondary arcuations to bend the endotracheal tube in conformance therewith as desired during the intubation procedure.

RELATED APPLICATION INFORMATION

This application is a continuation of U.S. application Ser. No.13/794,121, entitled “MANUALLY ARTICULATED INTUBATION STYLET, INTUBATIONDEVICE AND INTUBATION METHOD” filed on Mar. 11, 2013, which claimspriority from U.S. Provisional Application Ser. No. 61/609,442, entitled“MANUALLY ARTICULATED INTUBATION STYLET, INTUBATION DEVICE ANDINTUBATION METHOD” filed on Mar. 12, 2012, which are incorporated byreference herein in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to endotracheal intubation, andmore particularly to apparatuses and methods useful in the positioningof an endotracheal tube within the airway of a patient.

BACKGROUND OF THE INVENTION

Anesthesiologists and other medical care providers are often required tointubate patients in order to provide an adequate airway for the patientduring receipt of medical care. One manner of intubating a patientinvolves positioning an endotracheal tube into the patient's trachea.

Various implements can be used to assist in the process of positioningendotracheal tubes including, for example, Macintosh blades, Millerblades and intubation stylets. Macintosh blades generally comprise acurved-bladed implement and are typically used to lift a patient'svallecula out of the way providing the medical care provider a betterview of the patient's airway. Miller blades generally comprise astraight-bladed implement and are typically used to trap the patient'sepiglottis to better expose the patient's glottis and vocal cords. Anintubation stylet may be inserted within the lumen of an endotrachealtube. The stylet may be used with or without other implements (e.g.Macintosh blades and/or Miller blades) to help guide the tube into thepatient's trachea. After the endotracheal tube is properly positioned inthe patient's airway, the stylet is removed from the lumen of theendotracheal tube allowing a ventilator or the like to be attached tothe tube to ventilate the patient.

Despite the availability of various stylets and other implements, theinsertion of endotracheal tubes can be difficult even for skilledproviders, particularly in patient's having anterior tracheas and otherconditions that make it challenging to guide the distal end of theendotracheal tube into past the vocal cords and into the trachea. Insome instances where an endotracheal tube cannot be properly positionedat all or within a timely enough manner, the patient may need to have atracheotomy.

SUMMARY OF THE INVENTION

Accordingly, apparatuses and methods useful in the positioning of anendotracheal tube within an airway during an intubation procedure areprovided. The apparatuses and methods described herein are useful inassisting the intubation of patients in both routine and emergencyprocedures. The apparatuses and methods described herein areparticularly suited for intubating a human patient. However, theapparatuses and methods described herein may also be applicable to theintubation of non-human patients as well.

The apparatuses and methods provide, for example, the ability to morereadily insert an endotracheal tube into the trachea of a patient anddesirably avoid the need for a tracheotomy. The apparatuses and methodsfurther provide, for example, the ability to bend the endotracheal tubein more than one direction while the tube is being positioned in apatient's airway. The ability to bend the endotracheal tube in twodirections (e.g. a clockwise bend over a middle portion of the tube anda counter-clockwise bend over a distal end portion end of the tube)helps a medical care provider advance the distal end of the tube pastthe vocal cords and into the trachea of the patient, particularly in apatient having an anterior trachea or other challenging anatomy. Theapparatuses and methods further provide, for example, the ability tobend one portion of the endotracheal tube (e.g. the distal end portion)in one direction independent of a different portion of the endotrachealtube (e.g. a portion preceding the distal end portion) being bent inanother direction. The ability to independently bend different portionsof the tube affords the medical provider the ability to readilymanipulate the endotracheal tube as needed to accomplish positioning ofthe tube in a patient with challenging anatomy.

Advantages of the apparatuses and methods described herein furtherinclude, without limitation, the ability to control the shape of anendotracheal tube, the ability to respond to unique anatomicaldifferences in trachea location and shape, and the ability to utilize adisposable stylet while continuing to use other portions of theapparatus.

These and other features and advantages are achieved by various aspectsof the apparatuses and methods described herein. In one aspect, anapparatus useful in the positioning of an endotracheal tube within anairway comprises a stylet having a first end and a second end. Thesecond end of the stylet may be insertable within a lumen of theendotracheal tube such that at least a portion of a longitudinal extentof the stylet is received within the lumen of the endotracheal tube. Afirst filament may extend substantially parallel with a longitudinalaxis of the stylet. The first filament may be connected to the stylet ata first location between the first and second ends. A second filamentmay extend substantially parallel with the longitudinal axis of thestylet. The second filament may be connected to the stylet at a secondlocation farther from the first end than the first location. A firsttensioning mechanism may be operable to put the first filament undertension to articulate the stylet into a primary arcuation that mayextend from the first location toward the first end. A second tensioningmechanism may be operable to put the second filament under tension toarticulate the stylet into a secondary arcuation that may extend fromthe second location toward the first location.

In another aspect, an apparatus useful in the positioning of anendotracheal tube within an airway may comprise a stylet having a firstend and a second end. The second end of the stylet may be insertablewithin a lumen of the endotracheal tube such that at least a portion ofa longitudinal extent of the stylet is received within the lumen of theendotracheal tube. The stylet may comprise at least a firstarticulatable portion extending toward the first end from a firstlocation along a longitudinal extent of the stylet and a secondarticulatable portion extending toward the first location from a secondlocation along the longitudinal extent of the stylet farther from thefirst end than the first location. The first articulatable portion ofthe stylet may be articulatable into a primary arcuation and the secondarticulatable portion of the stylet may be articulatable into asecondary arcuation. In this regard, the first and second articulatableportions of the stylet may be independently articulatable intorespective primary and secondary arcuations.

In a further aspect, a method for positioning an endotracheal tubewithin an airway may comprise coupling a first end of a stylet with ahandle body including first and second articulating mechanisms. Thestylet may include a first articulatable portion extending toward thefirst end from a first location along a longitudinal extent of thestylet and a second articulatable portion extending toward the firstlocation from a second location along the longitudinal extent of thestylet farther from the first end than the first location. In thisregard, the first and second articulating mechanisms may beindependently operable. The method may further comprise inserting asecond end of the stylet within a lumen of the endotracheal tube suchthat at least a portion of the longitudinal extent of the stylet isreceived within the lumen of the endotracheal tube. The method mayadditionally comprise, concurrent with positioning the endotracheal tubewithin the airway, operating the first articulating mechanism toarticulate the first portion of the stylet into a primary arcuationand/or operating the second articulating mechanism to articulate thesecond portion of the stylet into a secondary arcuation.

Various apparatuses and methodologies are provided herein. Suchapparatuses and methodologies may be employed separately and incombination. Various refinements exist of the features noted in relationto the various aspects, and further features may also be incorporated inthe various aspects. These refinements and additional features may existindividually or in any combination, and various features of the variousaspects may be combined. These and other aspects and advantages will beapparent upon review of the following Detailed Description when taken inconjunction with the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective exploded view of one embodiment of a manuallyarticulatable intubation apparatus.

FIG. 2 is a side view of the manually articulatable intubation apparatusin which a stylet thereof is shown without any arcuations.

FIG. 3 is a side view of the manually articulatable intubation apparatusin which the stylet thereof is shown with a primary arcuation.

FIG. 4 is a side view of the manually articulatable intubation apparatusin which the stylet thereof is shown with a primary arcuation and asecondary arcuation.

FIG. 5 is a side view of the manually articulatable intubation apparatusin which the stylet thereof is shown with a secondary arcuation.

FIG. 6 is an exploded perspective view of one embodiment of a stylet ofthe manually articulatable intubation apparatus.

FIG. 7 is a perspective cross-sectional view of one-half of oneembodiment of a handle body of the manually articulatable intubationapparatus.

DETAILED DESCRIPTION

FIG. 1 shows one embodiment of a manually articulatable intubationapparatus 10. The manually articulatable intubation apparatus 10includes a handle body 20 that may be held in an upright position asillustrated. The manually articulatable intubation apparatus 10 alsoincludes an articulating stylet 50. The stylet 50 includes a first end50A proximal to the handle body 20 and a second end 50B distal from thehandle body 20. When assembled, the first end 50A of the stylet may beseated against a stylet seating surface 20A (not shown in FIG. 1) formedat the bottom of a stylet changing opening 30 (not shown in FIG. 1) inthe base of the handle body 20. The stylet seating surface 20A andstylet changing opening 30 may be seen in FIG. 7.

A major handle lever 22 and a minor handle lever 24 mount freely to thehandle body 20 on an axle pin 26. Major handle lever 22 may also bereferred to herein as first lever 22 and minor handle lever 24 may alsobe referred to herein as second lever 24. Axle pin 26 is received inaxle pin holes 28 formed in the handle body 20, the major handle lever22 and the minor handle lever 24 to mount the major and minor handlelevers 22, 24 on the handle body 20 in a pivotable manner about afulcrum provided by the axle pin 26. In other embodiments, the major andminor handle levers 22, 24 may be pivotably mounted on the handle body20 in other manners including, for example, by separate axle pins.

A first filament 74 and a second filament 76 extend from the first end50A of the stylet 50 and through the stylet changing opening 30 (shownin FIG. 7) into the open interior of handle body 20. The first filament74 also extends parallel with a longitudinal axis 52 of the stylet 50through a first longitudinal passageway 54 formed within the stylet 50to a first location 64 along a longitudinal extent of the stylet 50. Thefirst filament 74 is connected to the stylet 50 at the first location64. The first filament 74 may be connected with the stylet 50 at thefirst location 64 in a variety of manners including, for example, bysoldering the first filament 74 to the stylet 50 at the first location64. In this regard, the first filament 74 may comprise a metallic wire(e.g. a piano wire) and the stylet 50 may be comprised of metal at thefirst location 64. The second filament 76 also extends parallel with thelongitudinal axis 52 of the stylet 50 through a second longitudinalpassageway 56 formed within the stylet 50 to a second location 66 alongthe longitudinal extent of the stylet 50. The second filament 76 isconnected to the stylet 50 at the second location 66. The secondfilament 76 may be connected with the stylet 50 at the second location66 in a variety of manners including, for example, by soldering thesecond filament 76 to the stylet 50 at the second location 66. In thisregard, the second filament 76 may comprise a metallic wire (e.g. apiano wire) and the stylet 50 may be comprised of metal at the secondlocation 66. In other embodiments, the first and second filaments 74, 76may comprise materials other than metallic wire and/or may be connectedto the stylet 50 at the respective first and second locations 64, 66thereof in manners other than soldering.

The first and second filaments 74, 76 exit the interior of the handlebody 20 through a top slot 32 formed in an upper portion of the handlebody 20. The first filament 74 is connected to a first threadedtensioning screw 34 and the second filament 76 is connected to a secondthreaded tensioning screw 36. The first filament 74 may be connectedwith the first threaded tensioning screw 34 in a variety of mannersincluding, for example, by soldering the first filament 74 to the bottomof the first threaded tensioning screw 34. In this regard, the firstfilament 74 may comprise a metallic wire (e.g. piano wire) and the firstthreaded tensioning screw 34 may be comprised of metal. The secondfilament 76 may be connected with the second threaded tensioning screw36 in a variety of manners including, for example, by soldering thesecond filament 76 to the second threaded tensioning screw 36. In thisregard, the second filament 76 may comprise a metallic wire (e.g. pianowire) and the second threaded tensioning screw 36 may be comprised ofmetal. In other embodiments, the first and second threaded tensioningscrews 34, 36 may be comprised of non-metallic materials, and/or thefirst and second filaments 74, 76 may comprise materials other thanmetallic wire and/or may be connected to the respective first and secondthreaded tensioning screws 34, 66 in manners other than soldering.Regardless of the material comprising the first and second filaments 74,76, the first and second filaments 74, 76 may desirably have sufficientyield strength in order to avoid undesirable deformation during use ofthe manually articulatable intubation apparatus. In this regard, thefirst and second filaments 74, 76 may, for example, have a yieldstrength of about 20,000 pounds per square inch or greater.

The first threaded tensioning screw 34 is threaded into a firsttensioning thumb nut 38. The first tensioning thumb nut 38 sits freelyin a first gimbal 40. The first gimbal 40 is pinned freely to the majorhandle lever 22 via laterally extending gimbal pins 46 received ingimbal pin holes 48 formed in the major handle lever 22. In this regard,the first threaded tensioning screw 34, first tensioning thumb nut 38and first gimbal 40 may together comprise a first gimbal and tensionadjustment assembly connecting the first filament 74 to the major handlelever 22. The second threaded tensioning screw 36 is threaded into asecond tensioning thumb nut 42. The second tensioning thumb nut 42 sitsfreely in a second gimbal 44. The second gimbal 44 is pinned freely tothe minor handle lever 24 via laterally extending gimbal pins 46received in gimbal pin holes 48 formed in the minor handle lever 24. Inthis regard, the second threaded tensioning screw 36, second tensioningthumb nut 42 and second gimbal 44 may together comprise a second gimbaland tension adjustment assembly connecting the second filament 76 to theminor handle 20.

The first and second gimbal and tensioning adjustment assemblies allowfor an initial tension in the first filament 74 and/or the secondfilament 76 to be adjusted independently of one another. The firsttensioning thumb nut 38 sits freely in the first gimbal 40 allowing thefirst tensioning thumb 38 to be turned in order to adjust an initialtension on the first filament 74. For example, as the first tensioningthumb nut 38 is turned in one direction (e.g., clockwise), threads onthe first tensioning thumb nut 38 engage threads on the first threadedtensioning screw 34 moving the first threaded tensioning screw 34 uprelative to the major handle lever 22 thereby increasing an initialtension in the first filament 74 between the first gimbal 40 and thefirst location 64 of the stylet 50, and as the first tensioning thumbnut 38 is turned in an opposite direction (e.g., counter-clockwise),threads on the first tensioning thumb nut 38 engage threads on the firstthreaded tensioning screw 34 moving the first threaded tensioning screw34 down relative to the major handle lever 22 thereby decreasing aninitial tension in the first filament 74 between the first gimbal 40 andthe first location 64 of the stylet 50. The second tensioning thumb nut42 sits freely in the second gimbal 44 allowing the second tensioningthumb 42 to be turned to adjust an initial tension on the secondfilament 76. For example, as the second tensioning thumb nut 42 isturned in one direction (e.g. clockwise), threads on the secondtensioning thumb nut 42 engage threads on the second threaded tensioningscrew 36 moving the second threaded tensioning screw 36 up relative tothe minor handle lever 24 thereby increasing an initial tension in thesecond filament 76 between the second gimbal 44 and the second location66 of the stylet 50, and as the second tensioning thumb nut 42 is turnedin an opposite direction (e.g. counter-clockwise), threads on the secondtensioning thumb nut 42 engage threads on the second threaded tensioningscrew 36 moving the second threaded tensioning screw 36 down relative tothe minor handle lever 24 thereby decreasing an initial tension in thesecond filament 76 between the second gimbal 44 and the second location66 of the stylet 50. In this regard, the first tensioning thumb nut 38and the second tensioning thumb nut 42 may each include a knurledtexture on outside surfaces thereof to facilitate gripping of thetensioning thumb nuts 38, 42 when turning.

The first and second gimbal and tensioning adjustment assemblies alsohelp reduce lateral forces on the first and second filaments 74, 76 whenthe major and minor handle levers 22, 24 are pivoted on the axle pin 26.In this regard, the first and second gimbals 40, 44 pivot on theirgimbal pins 46 relative to the respective major and minor handle levers22, 24 as the respective major and minor handle levers 22, 24 arepivoted. This allows the first and second gimbal and tensioningadjustment assemblies to move up and down in response to pivoting of themajor and/or minor handle levers 22, 24 while maintaining the first andsecond threaded tensioning screws 34, 36 to which the first and secondfilaments 74, 76 are respectively connected to maintain a generallyvertical orientation thereby minimizing lateral forces on the first andsecond filaments 74, 76, particularly at the point of connection to thefirst and second threaded tensioning screws 34, 36.

The handle body 20 of the manually articulated intubation apparatus 10may be shaped and contoured such that the handle body 20 restscomfortably against the palm of a single hand, right or left, allowingthe major handle lever 22 and/or the minor handle lever 24 to be readilypulled by the fingers against the handle body 20 thereby pivoting on theaxle pin 26. The handle body 20 may be constructed of a sufficientlyrigid material so that the handle body 20 does not excessively deformduring use of the manually articulated intubation apparatus 10, such as,for example, a rigid plastic or a metal (e.g. stainless steel).

The portions of the major and minor handle levers 22, 24 engaged by thefingers to pull the major and minor handle levers 22 toward the handlebody 20 may be sufficiently long to provide leverage when pulled towardthe handle body 20 so that the first and second filaments 74, 76 can becomfortably put under sufficient tension. The minor handle lever 24 maybe provided with a sufficiently larger radius curved configuration incomparison to the major handle lever 22 to allow the minor handle lever24 to be pulled toward the tighter radius curved configuration of themajor handle lever 24 without requiring movement of the major handlelever 22 toward the handle body 20. The major and minor handles 22, 24may be constructed of a sufficiently rigid material so that the majorand minor handles 22, 24 do not excessively flex during use of themanually articulated intubation apparatus 10, such as, for example, anyplastic or metal sufficiently strong and rigid to maintain their contourduring use.

The first and second threaded tensioning screws 34, 36 may be made froma material sufficiently rigid enough to maintain their threads whileunder tension such as, for example, a metal (e.g., steel). The first andsecond tensioning thumb nuts 38, 42 may be made of any materialsufficiently rigid to maintain their outer surface knurl texture andtheir threads such as, for example a metal (e.g. steel). The first andsecond gimbals 40, 44 may be made from any sufficiently strong materialto withstand forces applied thereto by the initial tension on the firstand second filaments 74, 76 and upon pivoting of the major and minorhandles 22, 24 such as, for example, a metal (e.g., steel). The axle pin26 may be made of a material sufficiently hard and strong (e.g. a metal)to withstand repeated rotation of the major and minor handle levers 22,24 as well as the forces applied to the axle pin 26 as the fulcrum aboutwhich the major and minor handle levers 22, 24 pivot.

The second end 50A of the articulating stylet 50 is insertable withinthe lumen of an endotracheal tube. The articulating stylet 50 has asufficient longitudinal extent or length such that when fully insertedwithin the lumen of an endotracheal tube, the second end 50B of thestylet 50 reaches the internal tip of a standard endotracheal tube, andnot beyond. However, it may be possible to utilize the stylet 50 with anendotracheal tube that is shorter than standard length by not fullyinserting the stylet 50 into the lumen of the shorter endotracheal tubeor by having the second end 50B of the stylet 50 extend beyond theinternal tip of the shorter endotracheal tube. It may also be possibleto utilize the stylet 50 with an endotracheal tube that is longer thanstandard length by having second end 50B of the stylet 50 extend notquite to the internal tip of the longer endotracheal tube. Furthermore,it is possible that different length stylets 50 may be provided for usewith different length endotracheal tubes. The articulating stylet 50 canbe made of any material sufficiently hard and strong to withstand thecompressive forces applied thereto by tension in the first and secondfilaments 74, 76 such as, for example, a plastic material (e.g., DELRIN®available from DuPont corporation).

Referring now in particular to FIGS. 2, 3, 4, and 5, the manuallyarticulatable intubation apparatus 10 is shown with the articulatingstylet 50 in various stages of articulation. An exemplary endotrachealtube 80 represented by the dashed lines in FIGS. 2, 3, 4 and 5 is shownwith the stylet 50 being disposed within a lumen of the endotrachealtube 80. Various features that may be included in an endotracheal tubesuch as, for example, a cuff and an inflation tube, are not illustratedas part of the endotracheal tube 80 shown in the figures.

FIG. 2 shows the stylet 50 in a non-articulated state. In this regard,both the major handle lever 22 and the minor handle lever 24 are instatic, neutral positions without being pulled toward the handle body20. Further, the first and second tensioning thumb nuts 38, 42 have beenadjusted so that that an initial tension in the first and secondfilaments 74, 76 is minimal. Thus, the stylet 50 extends straight belowthe handle body 20 without any significant arcuation present in thestylet 50, and thus there is no bending of the endotracheal tube 80.

FIG. 3 shows the stylet 50 in a first articulated state. In this regard,the major handle lever 22 has been pulled toward the handle body 20while the minor handle lever 24 remains in a static, neutral positionwithout being pulled toward the handle body 20. Pulling the major handlelever 22 toward the handle body 20 pivots the major handle lever 22 onthe axle pin 28 lifting the first gimbal and tensioning assemblyconnecting the first filament 74 to the major handle lever 22 therebyplacing the first filament 74 under tension (or increased tension ifalready under initial tension as a result of adjustment to the firsttensioning thumb nut 38). The tension (or increased tension) in thefirst filament 74 places the stylet 50 under compression (or increasedcompression) from the first location 64 toward the first end 50A. Thecompressive forces result in the stylet 50 acquiring a primary arcuation90 extending from the first location 64 toward the first end 50A of thestylet 50. The degree of curvature of the primary arcuation 90 may bevaried by varying the position of the major handle lever 22 as well asturning the first tensioning thumb nut 38. Releasing the major handle 22to return to its static, neutral position allows the primary arcuation90 to be released from the stylet 50, for example, during withdrawal ofthe stylet 50 from the lumen of the endotracheal tube. When articulatedinto the primary arcuation 90, portions of the stylet 50 correspondingwith the primary arcuation 90 press against the interior sidewall of theendotracheal tube 80 forcing the endotracheal tube 80 to conform withthe primary arcuation 90.

FIG. 4 shows the stylet 50 in a second articulated state. In thisregard, both the major handle lever 22 and the minor handle lever 24have been pulled toward the handle body 20. As more fully describedelsewhere herein, pulling the major handle lever 22 articulates thestylet 50 into the primary arcuation 90, with the endotracheal tube 80bending in conformance with the primary arcuation 92. Pulling the minorhandle 24 toward the handle body 20 pivots the minor handle lever 22 onthe axle pin 28 lifting the second gimbal and tensioning assemblyconnecting the second filament 76 to the minor handle lever 24 therebyplacing the second filament 76 under tension (or increased tension ifalready under initial tension as a result of adjustment to the secondtensioning thumb nut 42). The tension (or increased tension) in thesecond filament 76 places the stylet 50 under compression (or increasedcompression) from the second location 66 toward the first location 64.The compressive forces result in the stylet 50 acquiring a secondaryarcuation 92 extending from the second location 66 toward the firstlocation 64 of the stylet 50. The degree of curvature of the secondaryarcuation 92 may be varied by varying the position of the minor handlelever 24 as well as turning the second tensioning thumb nut 42.Releasing the minor handle 24 to return to its static, neutral positionallows the secondary arcuation 92 to be released from the stylet 50, forexample, during withdrawal of the stylet 50 from the lumen of theendotracheal tube. When articulated into the secondary arcuation 92,portions of the stylet 50 corresponding with the secondary arcuation 92press against the interior sidewall of the endotracheal tube 80 forcingthe endotracheal tube 80 to conform with the secondary arcuation 92.

FIG. 5 shows the stylet 50 in a third articulated state. In this regard,only the minor handle lever 24 has been pulled toward the handle body 20while the major handle lever 22 remains in a static, neutral positionwithout being pulled toward the handle body 20. As more fully describedelsewhere herein, pulling the minor handle lever 24 articulates thestylet 50 into the secondary arcuation 92, with the endotracheal tube 80bending in conformance with the secondary arcuation 92.

Depending upon which of the major and minor handle levers 22, 24 arepulled, the stylet 50 may be varied among a non-articulated statewithout any arcuation, the first articulated state with only the primaryarcuation 90 present, the second articulated state with both the primaryarcuation 90 and secondary arcuation 92 present, and the thirdarticulated state with only the secondary arcuation 92 present. Further,the degree of curvature of both the primary and secondary arcuations 90,92 can be varied as desired, and the stylet 50 can be provided with thesecondary arcuation 92 independent of the presence of the primaryarcuation 90 and with the primary arcuation 90 independent of thepresence of the secondary arcuation 92.

FIG. 6 shows one embodiment of the articulating stylet 50 in an explodedview. The articulating stylet 50 is comprised of a plurality ofindividual beads 100. Beads 100 in different positions along thelongitudinal extent of the stylet 50 may have different configurations.For example, some of the beads 100 may be configured like the individualbead 100 shown in the enlarged view outlined by box 102, other beads 100may be configured like the individual bead 100 shown in the enlargedview outlined by box 104, and other beads 100 may be configured like theindividual bead 100 shown in the enlarged view outlined by box 106.

Regardless of their configuration, each individual bead 100 may have thefirst and second longitudinal passageways 54, 56 formed therethroughpermitting passage of the first and second filaments 74, 76 within thestylet 50. The first passageway 54 and second passageway 56 may beformed at first and second radial locations near the outer surface of anindividual bead 100. In this regard, the first and second radiallocations of the first and second passageways 54, 56 may be separated byabout 180 degrees measured around the circumference of the bead 100resulting in the first and second filaments 74, 76 being near the outersurface of the stylet 50 but on opposite sides of a cross-sectionaldiameter of the stylet 50. In other embodiments, one or more of theindividual beads 100 may be provided with only a single passagewaythrough which both of the first and second filaments 74, 76 extend.

The stylet 50 may be comprised of various series of differentlyconfigured individual beads 100. For example, there may be a firstseries 110 of beads 100 configured like the beads 100 shown in box 102,a second series 112 of beads 100 configured like the beads 100 shown inbox 104, and a third series 110 of beads 100 configured like the beads100 shown in box 106. The first series 110 of beads 100 may comprise aportion of the stylet 50 that may be articulated into the primaryarcuation 90, the second series 112 of beads 100 may comprise a portionof the stylet 50 that may be articulated into the secondary arcuation92, and the third series 112 of beads 100 may comprise a non-articulatedportion of the stylet 50 between the primary arcuation 90 and the firstend 50A of the stylet 50.

As illustrated in the enlarged view of box 106, each bead 100 includedin the third series 114 of beads 100 includes flat top and bottom endsurfaces 100A, 100B that are perpendicular or near perpendicular to theside surface 100C of the bead 100. As illustrated in the enlarged viewof boxes 102 and 104, each bead 100 included in the first series 110 andsecond series 112 of beads 100 includes top and bottom end surfaces100A, 100B that are at non-perpendicular angles with respect to the sidesurface 100C of the bead 100, providing the beads 100 of the firstseries 110 of beads 100 and second series 112 of beads 100 with angledor beveled end surfaces 100A, 100B. In this regard, angling or bevelingof the top and bottom end surfaces 100A, 100B of the beads 100 in thefirst and second series 110, 112 of beads 100 facilitates articulationof the stylet 50 into the respective primary and secondary arcuations90, 92 in response to tension in the respective first and secondfilaments 74, 76 received in the respective first and second passageways54, 56 by providing the stylet 50 with portions where compressive forcesresulting from tension in the first and second filaments 74, 76effectively shorten the length of the stylet 50 (on the inside of thecurve of the respective primary and secondary arcuations 90, 92) bybringing the top and bottom end surfaces 100A, 100B of adjacent beads100 in closer proximity. Further, the degree to which the end surfaces100A, 100B, of the beads in the first series 110 of beads 100 and thesecond series 112 of beads 100 are angled with respect to the sidesurfaces 100C of the beads 100 may be varied to control the amount ofcurvature in the primary and secondary arcuations 90, 92. For example,the end surfaces 100A, 100B of the beads 100 included in the firstseries of beads 110 may be angled such that the stylet 50 may bearticulated into a primary arcuation 90 having a radius of approximately2.5 inches.

In other embodiments, such as for example where the stylet 50 is notcomprised of individual beads 100 but rather a continuous longitudinalextent of material, notches or the like formed in the side surface ofthe stylet 50 may be provided to achieve a similar result. Additionally,in other embodiments, one or more of the beads 100 in the first and/orsecond series 110, 112 of beads 100 many have only one or no angled orbeveled end surfaces 100A, 100B.

As can be seen by comparing the enlarged views of boxes 102 and 104, theend surfaces 100A, 100B of the beads 100 in the first series 110 may beangled such that the length of the side surface 100C of the bead 100proximal to the first passageway 54 is shorter in length than the sidesurface 100C of the bead 100 proximal to the second passageway 56, andthe end surfaces 100A, 100B of the beads 100 in the second series 112may be angled such that the length of the side surface 100C of the bead100 proximal to the second passageway 56 is shorter in length than theside surface 100C proximal to the first passageway 54. Essentially, theangled end surfaces 100A, 100B of the beads 100 included in the secondseries of beads 112 may be oriented in an opposite direction to that ofthe end surfaces 100A, 100B in the first series of beads 110. Angling ofthe end surfaces 100A, 100B of the beads 100 included in the secondseries of beads 112 in an orientation opposite that of the end surfaces100A, 100B in the first series of beads 110 facilitates the secondaryarcuation 92 of the stylet 50 being oriented in an opposing direction tothat of the primary arcuation 90.

FIG. 7 shows a perspective cross-sectional view of one-half of oneembodiment of a handle body 20 of the manually articulatable intubationapparatus 10. The other half of the handle body 20 may be configured ina similar manner.

The handle body 20 includes an endotracheal tube slot 82 at the base ofthe handle body 20. The endotracheal tube slot 82 may be configured toreceive an endotracheal tube adaptor on the proximal end of anendotracheal tube 80 to secure a proximal end of the endotracheal tube80 to the handle body 20 during use of the manually articulatableintubation apparatus 10 such as depicted in FIG. 2, 3, 4, or 5. In thisregard, the endotracheal tube slot 82 may be large enough to accept astandard endotracheal tube adaptor, and small enough to hold it fixed.In this regard, a width of the endotracheal tube slot 82 may be suchthat the endotracheal tube adaptor may be press fit into the slot 82 toretain the tube 80 in proximity with the handle body 20 during insertionof the tube 80 into a patient's airway while articulating the stylet 50disposed within the lumen of the tube 80. Upon proper positioning of theendotracheal tube 80 within the patient's airway, the endotracheal tubeadaptor may be removed from the endotracheal tube slot 82 of the handlebody 20 as the stylet 50 is withdrawn from the interior of the tube 80.

The handle body 20 also includes a stylet changing opening 30 at thebase of the handle body 20. The first and second filaments 74, 76 (notshown in FIG. 7) extend through the stylet changing opening 30. In thisregard, the stylet changing opening 30 may be smaller in diameter than adiameter of the first end 50A of the stylet 50. The stylet seatingsurface 20A extends outwardly from the bottom edge of the styletchanging opening 30 and provides the surface against which the first end50A of the stylet 50 may be seated during using of the manuallyarticulated intubation apparatus 10. The handle body 20 may extend belowthe stylet seating surface 20A to provide an opening that receives aportion of the proximal end of the stylet 50 thereby stabilizing thefirst end 50A of the stylet 50.

The stylet changing opening 30 provides an opening in the handle body 20to feed the first and second threaded tensioning screws 34, 36 forinitial assembly and future replacement of the stylet 50. In thisregard, the stylet changing open 30 may have a diameter that issufficient for passage of the first and second threaded tensioningscrews 34, 36 therethrough. This allows for changing of the stylet 50.In this regard, the first and second filaments 74, 76 may bedisconnected from the respective major and minor handle levers 22, 24(e.g., by loosening the first and second tensioning thumb nuts 38, 42until disengaged from the threads of the first and second threadedtensioning screws 34, 36) and the stylet 50 may be pulled away from thehandle body 20 until the first and second threaded tensioning screws 34,36 pass through the stylet changing opening 30. Thereafter, first andsecond threaded tensioning screws 34, 36 connected to first and secondfilaments 74, 76 of another stylet 50 may be passed through the styletchanging opening 30, through the open interior of the handle body 20,out of the top slot 32 of the handle body 20, through the respectivefirst and second gimbals 40, 42 and connected to the respective majorand minor handle levers 22, 24 by tightening the respective first andsecond tensioning thumb nuts 38, 42 onto the respective first and secondthreaded tensioning screws 34, 36.

The handle body 20 also includes a plurality of snap hooks 84 along theinside perimeter of the handle body 20 half. During assembly, the snapshooks 84 may be received in corresponding snap hook retainers on theother half of the handle body 20 in order to retain the two halves ofthe handle body 20 together. The snap hooks 84 and their correspondingsnap hook retainers may be made of the same material as the rest of thehandle body 20. In this regard, the handle body 20 may be prepared by asingle casting, by injection molding, and/or by machining. The materialcomprising the handle body 20 may be sufficiently hard to withstand theforces of repeated use and shall be elastic enough to inhibit crackingduring normal use.

Deviations may be made from the specific embodiments disclosed in thespecification without departing from the spirit and scope of theinvention. The illustrations and discussion herein has only beenprovided to assist the reader in understanding the various aspects ofthe present disclosure. While this disclosure contains many specifics,these should not be construed as limitations on the scope of thedisclosure or of what may be claimed, but rather as descriptions offeatures specific to particular embodiments of the disclosure. Certainfeatures that are described in this specification in the context ofseparate embodiments and/or arrangements can also be implemented incombination in a single embodiment. Conversely, various features thatare described in the context of a single embodiment can also beimplemented in multiple embodiments separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations and even initially claimed as such, oneor more features from a claimed combination can in some cases be excisedfrom the combination, and the claimed combination may be directed to asubcombination or variation of a subcombination.

Additionally, the foregoing description of the present invention hasbeen presented for purposes of illustration and description.Furthermore, the description is not intended to limit the invention tothe form disclosed herein. Consequently, variations and modificationscommensurate with the above teachings, and skill and knowledge of therelevant art, are within the scope of the present invention. Theembodiments described hereinabove are further intended to explain bestmodes known of practicing the invention and to enable others skilled inthe art to utilize the invention in such, or other embodiments and withvarious modifications required by the particular application(s) oruse(s) of the present invention. It is intended that the appended claimsbe construed to include alternative embodiments to the extent permittedby the prior art.

1. An apparatus useful in the positioning of an endotracheal tube withinan airway, said apparatus comprising: a stylet having a first end and asecond end, said second end being insertable within a lumen of theendotracheal tube such that at least a portion of a longitudinal extentof said stylet is received within the lumen of the endotracheal tube; afirst filament extending substantially parallel with a longitudinal axisof said stylet, said first filament being connected to said stylet at afirst location between said first and second ends; a second filamentextending substantially parallel with a longitudinal axis of saidstylet, said second filament being connected to said stylet at a secondlocation farther from said first end than said first location; a firsttensioning mechanism operable to put said first filament under tensionto articulate said stylet into a primary arcuation extending from saidfirst location toward said first end; and a second tensioning mechanismoperable to put said second filament under tension to articulate saidstylet into a secondary arcuation extending from said second locationtoward said first location.
 2. The apparatus of claim 1 wherein saidsecond location coincides with said second end.
 3. The apparatus ofclaim 1 wherein said second location is between said first location andsaid second end.
 4. The apparatus of claim 1 wherein said primaryarcuation and said secondary arcuation are oriented in opposingdirections.
 5. The apparatus of claim 1 wherein said primary arcuationand said secondary arcuation are substantially co-planar.
 6. Theapparatus of claim 1 further comprising: an internal passagewayextending longitudinally within said stylet from said first end to saidsecond location, wherein both of said first and second filaments arereceivable in said internal passageway.
 7. The apparatus of claim 1further comprising: a first internal passageway extending longitudinallywithin said stylet from said first end to said first location, whereinsaid first filament is receivable in said first internal passageway; anda second internal passageway extending longitudinally within said styletfrom said first end to said second location, wherein said secondfilament is receivable in said second internal passageway.
 8. Theapparatus of claim 7 wherein said first internal passageway is proximalto an outer surface of said stylet at a first radial location relativeto said longitudinal axis of said stylet, and wherein said secondinternal passageway is proximal to an outer surface of said stylet at asecond radial location relative to said longitudinal axis of saidstylet.
 9. The apparatus of claim 8 wherein said first and second radiallocations are separated by about 180 degrees.
 10. The apparatus of claim1 wherein said first tensioning mechanism and said second tensioningmechanism are independently operable from one another. 11-15. (canceled)16. The apparatus of claim 1 wherein said stylet comprises a pluralityof individual beads.
 17. The apparatus of claim 16 wherein saidplurality of individual beads includes a primary series of beads and asecondary series of beads, wherein said primary series of beadscorresponds with said primary arcuation and wherein said secondaryseries of beads corresponds with said secondary arcuation.
 18. Theapparatus of claim 17 wherein at least one of said beads comprising saidprimary series of beads includes at least one beveled end surface, andwherein at least one of said beads comprising said secondary series ofbeads includes at least one beveled end surface.
 19. The apparatus ofclaim 1 wherein said stylet includes a plurality of individual notchesformed therein.
 20. The apparatus of claim 19 wherein said plurality ofindividual notches includes a primary series of notches and a secondaryseries of notches, wherein said primary series of notches are formed ina portion of a lengthwise extent of said stylet corresponding with saidprimary arcuation and wherein said secondary series of notches areformed in a portion of a lengthwise extent of said stylet correspondingwith said secondary arcuation.
 21. An apparatus useful in thepositioning of an endotracheal tube within an airway, said apparatuscomprising: a stylet having a first end and a second end, said secondend being insertable within a lumen of the endotracheal tube such thatat least a portion of a longitudinal extent of said stylet is receivedwithin the lumen of the endotracheal tube; said stylet comprising atleast a first articulatable portion extending toward said first end froma first location along a longitudinal extent of said stylet and a secondarticulatable portion extending toward said first location from a secondlocation along the longitudinal extent of the stylet farther from saidfirst end than said first location, said first articulatable portion ofsaid stylet being articulatable into a primary arcuation and said secondarticulatable portion of said stylet being articulatable into asecondary arcuation, said first and second articulatable portions ofsaid stylet being independently articulatable into respective saidprimary and secondary arcuations. 22-39. (canceled)
 40. A method forpositioning an endotracheal tube within an airway, said methodcomprising: coupling a first end of a stylet with a handle bodyincluding first and second articulating mechanisms, wherein the styletincludes a first articulatable portion extending toward the first endfrom a first location along a longitudinal extent of the stylet and asecond articulatable portion extending toward the first location from asecond location along the longitudinal extent of the stylet farther fromthe first end than the first location, and wherein the first and secondarticulating mechanisms are independently operable; inserting a secondend of the stylet within a lumen of the endotracheal tube such that atleast a portion of the longitudinal extent of the stylet is receivedwithin the lumen of the endotracheal tube; and concurrent withpositioning the endotracheal tube within the airway, performing at leastone of: operating the first articulating mechanism to articulate thefirst portion of the stylet into a primary arcuation; and operating thesecond articulating mechanism to articulate the second portion of thestylet into a secondary arcuation.
 41. The method of claim 40 whereinsaid performing at least one of operating the first articulatingmechanism to articulate the first portion and operating the secondarticulating mechanism to articulate the second portion comprises atleast one of: pivoting a first lever about a fulcrum to increase tensionin a first filament connected to the first lever and extendingsubstantially parallel with a longitudinal axis of the stylet, the firstfilament being connected to the stylet at the first location; andpivoting a second lever about a fulcrum to increase tension in a secondfilament connected to the second lever and extending substantiallyparallel with the longitudinal axis of the stylet, the second filamentbeing connected to the stylet at the second location.
 42. The method ofclaim 40 further comprising: withdrawing the stylet from the lumen ofthe endotracheal tube.
 43. The method of claim 42 further comprising:concurrent with said withdrawing the stylet from the lumen of theendotracheal tube, performing at least one of: operating the firstarticulating mechanism to release the primary arcuation from the firstportion of the stylet; and operating the second articulating mechanismto release the secondary arcuation from the second portion of thestylet. 44-48. (canceled)